Overview
Belladonna, also known as atropa belladonna or deadly nightshade, is a perennial herbaceous plant in the nightshade family Solanaceae. Its roots, leaves and fruits contain Hyoscyamine, Scopolamine, and mostly, Atropine. These alkaloids are naturally-occurring muscarinic antagonists. Atropine is a non-selective muscarinic antagonist that is mainly used as an adjunct for anaesthesia. The name "belladonna" originates from the Italian words "beautiful woman" and the historical use of herb eye-drops by women to dilate the pupils of the eyes for aesthetic purposes. Belladonna is a poisonous plant and belladonna intoxication from accidental ingestion may result in a severe anticholinergic syndrome, which is associated with both central and peripheral manifestations .
Background
Belladonna, also known as atropa belladonna or deadly nightshade, is a perennial herbaceous plant in the nightshade family Solanaceae. Its roots, leaves and fruits contain Hyoscyamine, Scopolamine, and mostly, Atropine. These alkaloids are naturally-occurring muscarinic antagonists. Atropine is a non-selective muscarinic antagonist that is mainly used as an adjunct for anaesthesia. The name "belladonna" originates from the Italian words "beautiful woman" and the historical use of herb eye-drops by women to dilate the pupils of the eyes for aesthetic purposes. Belladonna is a poisonous plant and belladonna intoxication from accidental ingestion may result in a severe anticholinergic syndrome, which is associated with both central and peripheral manifestations .
Indication
No therapeutic indications.
Associated Conditions
- Bloating
- Heartburn
- Menopausal Symptoms
- Poisoning of the Intestine
- Poisoning of the Stomach
- Reflux Acid
- Belching
- Gastrointestinal spasms
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
---|---|---|---|---|---|
2018/09/05 | Phase 4 | Completed | |||
2017/11/06 | Phase 4 | Completed | |||
2016/08/12 | Phase 4 | Terminated | Campbell Grant | ||
2015/11/09 | Phase 4 | Completed | Edgar LeClaire, MD | ||
2011/01/07 | Phase 4 | Completed | Loyola University | ||
2010/06/25 | Phase 4 | Completed | Kristina A. Butler | ||
2009/03/18 | Not Applicable | Completed |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
---|---|---|---|---|---|
Newton Laboratories, Inc. | 55714-2596 | ORAL | 15 [hp_X] in 1 mL | 5/21/2025 | |
King Bio Inc. | 57955-6031 | ORAL | 10 [hp_X] in 59 mL | 5/23/2025 | |
Newton Laboratories, Inc. | 55714-4862 | ORAL | 15 [hp_X] in 1 mL | 5/21/2025 | |
Bestmade Natural Products | 82969-6015 | AURICULAR (OTIC) | 30 [hp_C] in 30 [hp_C] | 5/27/2025 | |
King Bio Inc. | 57955-2830 | ORAL | 10 [hp_X] in 59 mL | 5/20/2025 | |
Laboratoire Schmidt-Nagel Inc. | 73296-004 | SUBLINGUAL, ORAL | 30 [hp_X] in 1 g | 5/20/2025 | |
Peaceful Mountain, Inc. | 43846-0079 | TOPICAL | 12 [hp_X] in 1 g | 5/21/2025 | |
Padagis US LLC | 0574-7045 | RECTAL | 16.2 mg in 1 1 | 8/8/2018 | |
Bryant Ranch Prepack | 63629-8435 | RECTAL | 16.2 mg in 1 1 | 5/12/2021 | |
Boiron | 0220-9333 | ORAL | 6 [hp_C] in 1 1 | 3/21/2025 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
---|---|---|---|
No EMA approvals found for this drug. |
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
---|---|---|---|---|---|
No HSA approvals found for this drug. |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
---|---|---|---|---|---|
No NMPA approvals found for this drug. |
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
---|---|---|---|---|---|
No PPB approvals found for this drug. |
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
---|---|---|---|---|---|
Traumeel Cream | 376439 | Medicine | A | 10/15/2021 | |
BRAUER DRY COUGH | 124132 | Medicine | A | 12/10/2005 | |
Baby & Child Teething Gel | 347981 | Medicine | A | 11/11/2020 | |
Mucosa compositum N | 124349 | Medicine | A | 12/19/2005 | |
TRAUMEEL S | 82622 | Medicine | A | 5/1/2002 |